ULTRA TUSS DM- guaifenesin dextromethorphan hbr syrup 
Ultra Seal Corporation

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Drug Facts

Active Ingredients (In 5 ml)

Guaifenesin   100 mg

Dextromethorphann HBr 10 mg

Purpose:Expectorant, Antitussive (Anti Cough)

Uses:temporarily:

• helps loosen phlegm (mucus)

• thin bronchial secretions to drain bronchial tubes, and make coughs more productive.

•    restores free breathing

•    suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

Warnings:

Do not use:

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

• more than the recommended dose.

Stop use and ask a doctor if:

• symptoms do not improve within 7 days or are accompanied by fever.

• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These can be signs of a serious condition.

Ask a doctor before use if you have:

• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if ou do not notice any signs or symptoms.

Directions:

Do not exceed 6 doses in any 24 hour period.

Adults and children 12 years of age and older: Take 2 teaspoons (10 ml) every 4 hours as needed, or as directed by a doctor.

Children 6-12 years: Take 1 teaspoon (5 ml) every 4 hours as needed, or as directed by a doctor.

Not to be used for children under 6 years of age.

Inactive Ingredients:Citric Acid, FD& C Red 40, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Purified water, Sodium Citrate, Sodium Saccharin

ultratuss dm 16 oz label

ULTRA TUSS DM 
guaifenesin dextromethorphan hbr syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
Colorred (cherry red) Score    
ShapeSize
FlavorCHERRY (sweet cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42213-161-93474 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/201212/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/19/201212/01/2021
Labeler - Ultra Seal Corporation (085752004)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(42213-161)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(42213-161)

Revised: 12/2023
 
Ultra Seal Corporation